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Medical Strategist

Austin Smith

Oncology drug developer and physician: first-in-human trials, radioligand theranostics, FDA/EMA/MHRA strategy.

Faculty of Pharmaceutical Medicine

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Areas of expertise

  • Biomarker strategy and diagnostics
  • Medical
  • Medical Devices
  • Research and clinical development
  • Research and Development

About Austin Smith

Austin Smith is a GMC-registered physician and pharmaceutical consultant with over 15 years in oncology drug development, dually trained in medical oncology and pharmaceutical medicine. He serves as Chief Medical Officer at Oxcia AB and Head of Clinical Development at Ariceum Therapeutics, leading early-phase and first-in-human programmes across haematological malignancies, radioligand theranostics, and orphan disease. His experience spans 80+ trials in oncology, haematology, CNS, respiratory, and immunology, across both medicinal products and devices. He advises on trial design, medical monitoring, PKPD, biomarker strategy, and orphan drug development, and brings multi-jurisdictional regulatory expertise across the FDA, EMA, and MHRA, including an MHRA ILAP advisory role and FPM Oncology and Clinical Trials Expert Group membership. He offers practical, experience-based guidance to biotech leaders, investors, and teams facing critical scientific, clinical, and regulatory decisions.

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